Active Ingredients:
Calendula officinalis -12C HPUS
Hamamelis virginiana - 6C HPUS
H-bi Hemorrhoids Formula Oil
FDA Label NDC 61077-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healing Natural Oils Llc for the product H-bi Hemorrhoids Formula (NDC 61077-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose, inactive ingredients:, indications:, directions:, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Calendula officinalis - 12C HPUS (healing agent),
Hamamelis virginiana - 6C HPUS (anus raw, bleeding).
The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States
Inactive Ingredients:
Corylus avellana nut oil, Essential Oil Blend (Helichrysum italicum flower,
Matricaria recutita flower, Pelargonium graveolens whole plant)
Indications:
For the temporary relief of hemorrhoid symptoms such as burning,
soreness and
minor bleeding
Directions:
Adults and Children 4 yrs and over: Wash hands before and after use.
Shake
well and apply 1 or 2 drops to a cotton swab or your finger and apply directly
to the affected area 3x per day.
Do not oversaturate or exceed dosage.
Warnings:
For external use only.
Perform skin test prior to initial use.
Otc - Pregnancy Or Breast Feeding
Do not use if pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
Keep away from eyes and mucous membranes. If swallowed get medical help or
contact a Poison Control
Center right away.
Otc - Stop Use
Discontinue use if irritation occurs.
Otc - Ask Doctor
Consult a doctor if symptoms worsen after 7 days.
Description
| Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA |
Package Label.Principal Display Panel
Healing Natural Oils
H-BI Hemorrhoids
Formula
Homeopathic
For External Use Only
005
11ml (0.37 fl. oz)
amoils.com
* Please review the disclaimer below.
